Regulatory Affairs Manager
5 months ago
Regulatory Affairs Manager - Medical Devices IVD
**Responsibilities**:
Develop and execute effective regulatory strategies and plans for medical devices IVD, focusing on compliance with Thai FDA regulations. Collaborate closely with cross-functional teams to ensure regulatory compliance throughout the product lifecycle, encompassing development, manufacturing, and post-market activities. Prepare and submit regulatory submissions, including product registrations, variations, and renewals, to the Thai FDA in a timely and accurate manner. Stay abreast of the latest Thai FDA regulations, guidelines, and industry trends related to medical devices IVD. Act as the primary point of contact for regulatory authorities, overseeing inspections, audits, and inquiries with professionalism and efficiency. Provide valuable guidance and support to the product development team, ensuring regulatory requirements are incorporated into the design and development processes. Maintain a strong knowledge of regional regulatory requirements and assist in expanding regulatory activities to other countries within the region. Manage and mentor a dedicated team of two direct reports, providing leadership, training, and ongoing performance feedback.
**Requirements**:
- A minimum of 5 years experience in regulatory affairs for medical devices, specifically with a focus on IVD.
- Extensive knowledge and hands-on experience with Thai FDA regulations and guidelines for medical devices.
- A solid understanding of the product registration process, including preparation of dossiers and familiarity with submission requirements.
- Some prior exposure to regional regulatory affairs within Southeast Asia would be considered a significant advantage.
- Previous experience working within the dynamic environment of an MNC is highly desirable.
- Exceptional written and verbal communication skills in English to effectively engage with stakeholders at all levels.
- Proven leadership capabilities, including the ability to motivate and inspire a team.
- A proactive and detail-oriented approach, with excellent multitasking abilities to effectively manage deadlines.
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